Job Summary
Join our dynamic team and make a lasting impact on patient lives. As the Director, Clinical Operations, you'll lead the charge in executing on groundbreaking clinical evidence that drives our diagnostics business forward and will be a member of the Clinical Affairs leadership team responsible for influencing and shaping a team culture. Your mission will involve shaping the future of healthcare by spearheading innovative clinical studies, mentoring and inspiring a talented team, and collaborating with key stakeholders to deliver exceptional clinical programs.

Essential Duties and Responsibilities
The incumbent may be asked to perform other function-related activities in addition to the below-mentioned responsibilities as reasonably required by business needs.
•    Directs strategic global clinical evidence operational execution throughout the new product development process for the diagnostics business.
•    Collaborates with key internal and external stakeholders to lead the execution of clinical studies for global new product development and product life cycle management.
•    Leads a team of 10 Clinical Trial Leads and Clinical Research Monitors. Oversees, trains and develops functional-area staff.
•    Participates in the development and execution of efficient and effective methods and procedures for Clinical Affairs programs and people. 
•    Directs clinical projects/programs consistent with Good Clinical Practice, company and department procedures and regulatory requirements 
•    Fosters a collaborative high-performing environment with project teams and functional leads in Compliance, Biostatistics, SAS Programming, Data Management, Medical Writing and Clinical Science. 
•    Works with team members to ensure scientific integrity of data by assisting in the development of data collection/review/analysis materials (e.g., CRFs, statistical analysis plans)
•    Evaluates current systems and identify ways to improve efficiency, champions continuous improvement of processes within and across departments. 
•    Works closely with Clinical Affairs leadership to plan resourcing and actively manages budgets.

Qualifications 
Education     
•    Minimum Bachelor’s degree in Life Sciences or equivalent qualification  

Experience    
•    Minimum of 10 years of progressive experience in clinical research within biotech or medical device industry
•    Minimum of 8 years of experience managing professional associates
•    Significant experience in resource and budget management and allocations across projects is required, including managing multiple clinical projects.
•    Must have a demonstrated ability to solve problems with innovative solutions along with strong organizational skills.

Skills
•    Excellent working knowledge of GCP, clinical and regulatory affairs.
•    Excellent project management skills with ability to deliver projects on time and on budget to support corporate goals and objectives.
•    Ability to conceptualize abstract processes and visualize solutions to complex problems.
•    Expert knowledge of clinical trial and research principles.
•    Strong understanding of the clinical study process including study design, conduct, management and data analysis.
•    Flexibility in daily activities and innovative problem solving skills.
•    Demonstrated strong project management skills.
•    Excellent interpersonal skills.


So why join Hologic?

We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.

The annualized base salary range for this role is $187,600 to $258,300 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.

Agency and Third Party Recruiter Notice: Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter.  All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

#LI-JS1